Home GUDID D943N5532B00 Power Dental U.S.A., Inc.
Primary DI D943N5532B00
Brand Power Dental U.S.A., Inc.
Company Power Dental U.S.A. Inc.
Model N5532B
Catalog number N5532B
Device description NEEDLE HOLDER PREMIUM BLACK EDITION SET OF 7
Published 2021-07-13
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name FHQ HOLDER, NEEDLE, GASTROENTEROLOGIC
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D943N5532B00 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Suturing needle holder, reusable A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 081305064 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true Combination product false Lot or batch false Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D94320240 Power Dental USA 2024 2024 2021-06-20 D94341260 Power Dental USA 4126 4126 2021-06-20 D943ORCAA0 Power Dental USA ORCAA ORCAA 2021-06-20 D94367350 Power Dental USA 6735 6735 2021-06-20 D94367380 Power Dental USA 6738 6738 2021-06-20 D94367390 Power Dental USA 6739 6739 2021-06-20 D94367410 Power Dental USA 6741 6741 2021-06-20 D94367430 Power Dental USA 6743 6743 2021-06-20 D94367140 Power Dental USA 6714 6714 2021-06-20 D94367420 Power Dental USA 6742 6742 2021-06-20 D9436710E0 Power Dental USA 6710E 6710E 2021-07-13 D94367310 Power Dental USA 6731 6731 2021-06-20 D94367320 Power Dental USA 6732 6732 2021-06-20 D94367150 Power Dental USA 6715 6715 2021-06-20 D9436716 Power Dental USA 6716 6716 2021-06-20 D9436733 Power Dental USA 6733 6733 2021-06-20 D9436734 Power Dental USA 6734 6734 2021-06-20 D9436740 Power Dental USA 6740 6740 2021-06-20 D9436750 Power Dental USA 6750 6750 2022-01-08 D9431007E0 Power Dental USA 1007E 1007E 2021-07-13
Other Devices Sharing Product Codes# 
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